Our client, a Biotech development and manufacturing company with rich pipeline, will now hire an Associate Director for Manufacturing Science & Technology (MS&T) who will be a member of the Biotech management team and a key leader in the cross functional support of the Large Molecule business and operations.
The MS&T Associate Director is responsible for MS&T business processes including support of new product introduction and technology transfer, process validation, process monitoring, productivity and continuous improvement projects.
Additionally, the MS&T Associate Director provides leadership and direction to the MS&T representatives in their area, to ensure that they meet their short to medium term goals including day to day technical operations support, NPI delivery as well as continuous improvement projects within the area.
Active member of the cross-functional, manufacturing support large molecule management team, understanding the business and their role to ensure the large molecule business objectives are met.
Supervision and coaching of large molecule MS&T representatives including completing performance reviews and development planning, to ensure continued growth of technical depth and capability with the team.
Oversight of MS&T staffing and resource allocation to support operations, NPI and Process Validation activities, and productivity/continuous improvement initiatives.
Provide technical oversight as needed for process related deviations and investigations.
Review and approve specific quality documents consistent with procedural requirements; including, but not limited to, deviations, change controls, APRs and validation documentation.
Active participation in ensuring a continued state of cGMP compliance and readiness for Pre-Approval Inspections (PAIs) and Routine GMP Inspections by various regulatory agencies.
Promote continued alignment in technical operations across the company’s large molecule facilities, and across the wider company mAb network.
Support further improvements in alignment where opportunities exist.
Minimum Masters in a Biological Science or Engineering discipline.
Preferred 10 years industrial experience in a cGMP environment.
Proven technical capability within a Large Molecule Manufacturing environment.
Proven GMP Manufacturing experience and New Product Introduction Knowledge.
Leadership experience through existing or previous roles.
For further details, please contact Larry on +353 (0) 1-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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